Heff Med HM-D870

GUDID 00850003355412

Dome Bag 198"

EXACT MEDICAL MANUFACTURING, INC.

Medical equipment drape, single-use

• Primary Device ID: 00850003355412
• NIH Device Record Key: 6d6e5a3a-0f69-49e2-88d3-ee49a989d4cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Heff Med
• Version Model Number: HM-D870
• Catalog Number: HM-D870
• Company DUNS: 014464314
• Company Name: EXACT MEDICAL MANUFACTURING, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850003355405 [Primary]
GS1	00850003355412 [Package]; Contains: 00850003355405; Package: Case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101689

FDA Product Code

• KKX: Drape, Surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-06
• Device Publish Date: 2019-06-18

On-Brand Devices [Heff Med]

• 00850003355412: Dome Bag 198"
• 10850003355389: C-Arm X-Ray Tube Cover
• 10850003355396: Mini C-Arm Drape 48" X 84"
• 10850003355372: Mini C-Arm Drape 42" X 74"
• 10850003355365: Heff Med Foot Pedal Drape 17" x 15"